Regulatory Focus™ > News Articles > Regulatory Recon: FDA Advisory Panel Backs Celltrion's Remicade Biosimilar in 21-3 Vote (10 February

Regulatory Recon: FDA Advisory Panel Backs Celltrion's Remicade Biosimilar in 21-3 Vote (10 February 2016)

Posted 10 February 2016 | By Michael Mezher 

Regulatory Recon: FDA Advisory Panel Backs Celltrion's Remicade Biosimilar in 21-3 Vote (10 February 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA advisory panel strongly backs biosimilar Remicade (Reuters) (Bloomberg) (WSJ) (Press) (Biosimilar News)
  • Senate Committee Advances Seven Bills Linked to Drug, Device Regulations and Research (Focus) (SCRIP-$) (Pink Sheet-$) (Gray Sheet-$)
  • How a Sanofi Diabetes Bet Went Wrong (WSJ-$)
  • Photos Snapped During FDA Device Inspections: Fair Game Or Agency Overreach? (Gray Sheet-$)
  • Obama's FY 2017 Budget Request: $5.1B for FDA, New Ways to Tackle High Drug Prices (Focus) (FDA) (Law360-$)
  • Top US Intelligence Official Calls Gene Editing a WMD Threat (MIT Technology Review)
  • Alternative Proposals for Lab Test Regulation (GenomeWeb)

In Focus: International

  • Starting to implement the EU MDR (QServe)
  • EU Regulation Requires New Safety Features on Drug Packaging by 2019 (Focus) (SCRIP-$)
  • Impacts of Deal Making on the Generic Market (Thomson Reuters)
  • Study in Brazil Links Zika Virus to Eye Damage in Babies (NYTimes) (ICT) (JAMA)
  • Gene drives need global policing (The Guardian)
  • Egregious Data Integrity Failures at Ipca Laboratories (Unger Consulting) (24 Insight) (Focus)
  • Australia set to legalize cultivation of medical cannabis (Reuters)

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US: Pharmaceuticals & Biotechnology

  • Orphan Drug Approvals Dipped in 2015, While Designations and Designation Requests Continue Upward Trend (FDA Law Blog)
  • Immunization Policy and the Importance of Sustainable Vaccine Pricing (JAMA)
  • Proposal to Permit the FDA to Rely on Journal Articles to Approve High-Risk Medical Devices Is Misguided (Public Citizen)
  • Time for Pharma to Catch Up With the FDA (Geeks Talk Clinical)
  • FDA puts full clinical hold on CTI BioPharma's blood cancer drug (Reuters)
  • Taming Drug Prices by Pulling Back the Curtain Online (NYTimes)
  • The future of the FDA and drug regulations (Science Roll)
  • The FDA Is Finally Ending Generic Inflation—and Hurting Wholesaler Profits (Drug Channels)
  • CRISPR Execs Talk Scientific, Regulatory Hurdles At BIO Panel (Xconomy)
  • #BIOCEO16 Session Recap: Regulatory Policy Outlook—PDUFA VI and You (BIO)
  • Amgen and biochemist Bruce Alberts have created a new online journal, looking to reveal often hidden results in biomedicine (MedCityNews)
  • Biogen CEO: Crush drug prices, and you crush drug R&D (MedCityNews)
  • AbbVie, Maker of World's No. 1 Drug, Bets Synthetic Biology Startup Can Raise the Bar (Forbes)
  • CRO market to reach $45.2bn by 2022 (Outsourcing-Pharma)
  • Alkermes CEO Richard Pops Isn't Giving Up On Breakthrough Depression Drugs (Forbes)
  • Brain Injury Diagnostics Workshop Planned By FDA (Gray Sheet-$) (FDA)
  • Regeneron's Eylea Soars, But Praluent Is Slow Out Of The Gate (Pink Sheet-$)
  • Innovative Therapies Require Modern Manufacturing Systems (PharmTech)

US: Pharmaceuticals & Biotechnology: Clinical Study Results, Filings & Designations

  • Merck files house dust mite allergy pill in the US (PharmaTimes)
  • Cidara Receives Orphan Drug Designation for Novel Echinocandin, CD101 IV, in Candidemia and Invasive Candidiasis (Press)
  • vTv Therapeutics Completes Enrollment of Phase 2b Trial Evaluating TTP399 for the Treatment of Type 2 Diabetes (Press)
  • Alkermes Announces Initiation of Second Phase 3 Study of ALKS 3831 for Schizophrenia (Press)
  • Allena Pharmaceuticals Initiates Patient Treatment in Third Phase 2 Trial of ALLN-177 for Secondary Hyperoxaluria (Press)
  • Amarantus Receives Orphan Drug Designation From the US FDA for Eltoprazine in the Treatment of Parkinson's Disease Levodopa-Induced Dyskinesia (Press)
  • FDA Grants Breakthrough Designation to Adaptimmune's T-Cell Therapy (DD&D) (Press)
  • Positive Phase 1b results for Heptares' HTL9936 (EPR)

US: Medical Devices

  • Building a Case for Medical Device Interoperability: FDA's Call to Action (FDA Voice) (Focus)
  • Former Google executive to lead cancer diagnostics firm (Reuters) (Forbes)
  • Blood test giving false sense of security about cancer risk? (CBS)
  • In modern-day gold rush of genetic testing, profit placed above proof (CBS)
  • Microfluidic Chip Mimics Smallest Capillaries to Study How Drugs Affect the Mechanics of Cells (medGadget)
  • Final Independent Assessment of FDA's Premarket Review Process Released (Emergo)
  • CorMatrix wins FDA nod for Tyke neonate cardiac tissue (MassDevice)
  • Podcast + Q&A: Combo Product Human Factors Guidance Follows Multi-Year Coalition Effort (Gray Sheet-$)
  • BD Receives FDA 510(k) Clearance for Diagnostic Device for HIV/AIDS (Press)
  • TransEnterix Finalizes FDA Submission Process Related to SurgiBot System 510(k) Application (Press)
  • Philips secures 510(k) clearance to market new patient monitoring solution to bring bedside quality monitoring to the MR suite (Press)

US: Assorted & Government

  • Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds (Drug and Device Law)
  • 'Right to Try' drug bill for terminally ill advances in Iowa Senate (Des Moines Register)
  • PhRMA Statement on President's FY2017 Budget (PhRMA)
  • Senator Scrutinizes Pharma Links on Government Pain Panel (DD&D)
  • How Pharma Cos. Can Lessen The Risk Of Gov't Action (Law360-$)
  • Boston Scientific wins CMS coverage for Watchman LAAC (MassDevice)

Upcoming Meetings & Events


  • EMVO welcomes formal publication of Commission Delegated Regulation (EU) 2016/161 (EFPIA)
  • NICE publishes new myeloma guidance (Pharmafile)
  • NICE rejects Roche's Kadcyla for NHS; price still too high (Pharmafile)
  • Novartis says CDF proposals place "unreasonable" risk on pharma (Pharmafile)
  • UK MHRA Postpones April Target Date For New Device Fees (SCRIP-$)
  • Axinesis wins CE Mark for robotic rehab device (MassDevice)
  • Marketing authorisations granted in January 2016 (MHRA)


  • Indian drugs cheaper, says Government on withdrawing duty exemption (Economic Times)
  • Six Dead in India Pharma Factory Explosion (Pharmaceutical Manufacturing)
  • Mumbai Court rejects union's claim against Sun Pharmaceutical Industries (Economic Times)
  • Union govt keen to see India replicate generic drugs success in APIs too (PharmaBiz)
  • Experts from WHO to give training to Gujarat FDCA officials on GRP & NRA assessment tool (PharmaBiz)
  • Glenmark Approved for Generic Lotrisone Cream (MPR)
  • Health ministry to monitor all 1163 blood component separation facilities in country (PharmaBiz)



  • Consultation – New proposed monograph (First Aid Antiseptics) (Health Canada)

Zika Virus

  • China confirms first case of Zika virus: Xinhua (Reuters)
  • EMA Sets Up Task Force To Offer Advice on Zika Research and Development (SCRIP-$) (Focus)
  • US to study Zika link to Guillain-Barre in Puerto Rico (Reuters)
  • Global medicines regulators pledge support to tackle Zika virus disease (MHRA)
  • Zika, disease of the poor, may not change abortion in Brazil (Reuters)
  • ENVI, WHO Exchange of Views on Zika Virus – 17 February 2016 (ENVI)
  • World Bank ramps up discussions on Zika response (DevEx)
  • Nearly 100 nerve disorder cases linked to Zika in Colombia: health officials (Reuters)

Other International

  • Ebola Still Takes Mental Toll on West Africa's 'Burial Boys' (WSJ)
  • In Egypt, medicines disappear from shelves as dollar crisis bites (Reuters)
  • Sanofi banks on Philippines to lead public Dengvaxia rollout (FiercePharmaAsia)

General Health & Other Interesting Articles

  • Johns Hopkins becomes first center in country to offer HIV-positive to HIV-positive organ transplants (Washington Post)
  • Preventable injury deaths shorten US life expectancy (Reuters)
  • WHO Issues Influenza Risk Assessment (ICT)
  • Biggest ever infectious disease survey to speed end of trachoma (Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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